Vitamin D Deficiency in Patients With Hypertension



Status:Terminated
Conditions:High Blood Pressure (Hypertension), Other Indications, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology, Other
Healthy:No
Age Range:21 - Any
Updated:4/17/2018
Start Date:August 2009
End Date:December 2011

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Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension

This study will evaluate the effects of Vitamin D replacement and the effects of an approved
medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who
have low levels of vitamin D in their blood. The study will compare the effects of vitamin D
or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.

This study will assess whether aliskiren will lower clinic blood pressure and 24-hour blood
pressure in patients with hypertension and vitamin D deficiency. Additionally, this study
will further explore the potential additional effects of adding vitamin D to aliskiren in
this patient population.

Inclusion Criteria:

- Men or women over 21 years of age with a history of Stage 1 or 2 hypertension (defined
as a seated diastolic BP ≥ 90 mmHg and < 110 mmHg in the untreated state).

- Patients under treatment for hypertension must be willing and able to discontinue any
previous antihypertensive medications for the duration of the study.

- 25-hydroxyvitamin D levels < 30 ng/ml and > 12 ng/ml.

- Women of childbearing potential must be using a medically acceptable form of birth
control for the duration of the trial, must have a negative serum pregnancy test at
screening, and must have a negative urine pregnancy test within 7 days before
initiating aliskiren therapy.

Exclusion Criteria:

- Vitamin D levels < 12 ng/ml

- Known hypersensitivity or allergy to aliskiren

- Clinic blood pressure > 180/110 mmHg

- Known forms of secondary hypertension

- Chronic atrial fibrillation

- Uncontrolled or unstable cardiovascular diseases

- Shift or night workers

- Mid-arm circumference > 42 cm in diameter

- Current or recent (<1 year) alcohol or drug abuse

- Pregnant or lactating women
We found this trial at
1
site
263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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